Entocort^®

Budesonide 3 mg capsules

What Entocort is used for

Entocort is used to treat Crohn's disease. It can be used to treat acute attacks.

Crohn's disease is an inflammatory disease of the bowel. It mainly affects the small bowel and the first part of the large bowel and causes symptoms such as stomach pain, diarrhoea and fever.

How Entocort works

Entocort belongs to the family of corticosteroids, which are used to treat inflammation in many parts of the body.

Entocort capsules are designed to release their contents gradually in the last part of the small bowel (the ileum) and the first part of the large bowel. Hence the name Entocort CIR - 'controlled ileal release'. Entocort capsules reduce inflammation in the small bowel and also in the first part of the large bowel.

Your doctor will have explained why you are being treated with Entocort and told you what dose to take.

Follow your directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Entocort is not addictive.

Before you use Entocort

When you must not use it

Do not use Entocort if you are pregnant, think you might be pregnant or are breastfeeding unless your doctor says to do so. Ask your doctor about the risks and benefits involved. There is very limited experience with Entocort capsules in pregnant or breastfeeding women.

Do not give Entocort to children. There is only limited information available about the use of Entocort in children.

Do not use after the use by (expiry date) printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Before you start to use it

1. You have any allergies to:

• any ingredients listed at the end of this leaflet
• any steroid preparation (inhaled, oral or cream)
• any other substance.

1. You have any of these medical conditions:

• any recent infection, or tuberculosis
• diabetes
• liver disease
• brittle bones (osteoporosis)
• stomach ulcers
• high blood pressure
• glaucoma or cataracts.

1. If you have NOT had chicken pox or measles.

Taking other medicines

These medicines may affect the way Entocort works.

Your doctor or pharmacist can tell you what to do if you are taking any other medicines.

Using Entocort

How to take it

Swallow Entocort capsules whole with a glass of water. Do not crush or chew the capsules. If the granules are chewed or crushed they won't work properly.

Always eat some food after you take Entocort.

The usual dose of Entocort when your Crohn's disease is active is 9 mg per day. This is usually taken as a single dose in the morning. This dose usually continues for up to 8 weeks.

It may take 2-4 weeks to get the full effect from Entocort. Do not forget to take it even if you feel better.

Treatment with Entocort must not be stopped suddenly. The dose needs to be reduced over the last 2-4 weeks.

Follow your doctor's directions carefully. They may differ from the information contained in this leaflet.

If you forget to take it

If you forget to take an occasional dose of Entocort capsules it is not necessary to make up for the dose you missed. Just take the next dose as usual.

If you have trouble remembering when you take your medicine, ask your pharmacist or doctor for some hints.

Overdose

While you are using Entocort

Things you must not do

Do not take Entocort with grapefruit or grapefruit juice. Grapefruit juice, but not other fruit juices, may increase the effect of Entocort.

Do not stop taking Entocort unless your doctor tells you to. You need to reduce the dose gradually before stopping.

Things to be careful of

Tell your doctor if you have an infection while you are taking Entocort. It may not be safe for you to continue taking Entocort if you have an infection.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

Side effects

Entocort helps most people with Crohn's disease, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

• swelling of the face
• bruising
• indigestion
• menstrual problems
• nervousness, sleeplessness and mood swings
• muscle cramps
• unusually fast or irregular heartbeats
• blurred vision
• skin rash or itchiness.

If your medicine has been changed from 'cortisone' capsules (eg. prednisolone) to Entocort capsules, you may notice symptoms such as rash, or pain in muscles and joints. If this happens or you get headaches, feel sick, vomit, or fell tired please contact your doctor.

Some people may get other side effects while taking Entocort.

Important: This leaflet alerts you to some of the situations when you should call your doctor. Other situations, which cannot be predicted, may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using Entocort.

After using it

Storage

Keep your capsules in the bottle until it is time to take them. Replace the cap firmly after use. If you take Entocort out of the bottle it will not keep well.

Do not store Entocort or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep Entocort where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Product description

What Entocort looks like

Entocort is a hard gelatine capsule, with an opaque, light grey body and an opaque, pink cap. It is printed with CIR 3 mg, and comes in packs of 100.

Ingredients

Each Entocort capsule contains 3 mg of micronised budesonide as the active ingredient, plus:

• ethylcellulose
• acetyltributyl citrate
• methacrylic acid copolymer
• triethylcitrate (E1505)
• antifoam M
• polysorbate 80 (E433)
• talc [E553b]
• sucrose